Small Study Group Research Articles

Odor recognition memory is not independently impaired in Parkinson’s disease

The results of previous studies in small groups of Parkinson's disease (PD) patients are inconclusive with regard to the presence of an odor recognition memory impairment in PD. The aim of the present study was to investigate odor recognition memory in PD in a larger group of patients. Odor recognition memory and detection thresholds were assessed using components of the "Sniffin' Sticks" test battery in 55 non-demented PD patients (Hoehn and Yahr stages I-III) and 50 control subjects of comparable age and sex. PD patients performed slightly but significantly worse than control subjects on the odor recognition memory task. After correction for odor detection scores, however, the difference in odor recognition memory performance between PD patients and controls was no longer statistically significant. These data indicate that odor recognition memory is not independently impaired in PD patients.

My Life with Self Psychology

In this very personal writing, I describe my experiences with self psychology in general and with Heinz Kohut in particular, from its beginnings in the early 1970s until Kohut's death and my own subsequent development. The discovery of self psychology in the context of my beginnings as a new, rather disillusioned, candidate in a classical institute affiliated with the American Psychoanalytic Association is described, with the sense of relief that comes with finding a theoretical perspective that matched my own views about human beings. My experiences as a member of the small study group that met in Chicago under the leadership of Kohut, what that was like for me, and how I came to both grow under his influence and then to find my own voice from within that influence forms the majority of this essay of deep appreciation for Kohut the man and Kohut the founder of a psychoanalytic theory.

Endurance exercise and DNA stability: Is there a link to duration and intensity?

It is commonly accepted that regular moderate intensity physical activity reduces the risk of developing many diseases. Counter intuitively, however, evidence also exists for oxidative stress resulting from acute and strenuous exercise. Enhanced formation of reactive oxygen and nitrogen species may lead to oxidatively modified lipids, proteins and nucleic acids and possibly disease. Currently, only a few studies have investigated the influence of exercise on DNA stability and damage with conflicting results, small study groups and the use of different sample matrices or methods and result units. This is the first review to address the effect of exercise of various intensities and durations on DNA stability, focusing on human population studies. Furthermore, this article describes the principles and limitations of commonly used methods for the assessment of oxidatively modified DNA and DNA stability. This review is structured according to the type of exercise conducted (field or laboratory based) and the intensity performed (i.e. competitive ultra/endurance exercise or maximal tests until exhaustion). The findings presented here suggest that competitive ultra-endurance exercise (>4h) does not induce persistent DNA damage. However, when considering the effects of endurance exercise (<4h), no clear conclusions could be drawn. Laboratory studies have shown equivocal results (increased or no oxidative stress) after endurance or exhaustive exercise. To clarify which components of exercise participation (i.e. duration, intensity and training status of subjects) have an impact on DNA stability and damage, additional carefully designed studies combining the measurement of DNA damage, gene expression and DNA repair mechanisms before, during and after exercise of differing intensities and durations are required.

TWELVE-MONTH SAFETY AND VISUAL ACUITY RESULTS FROM A FEASIBILITY STUDY OF INTRAOCULAR, EPIRETINAL RADIATION THERAPY FOR THE TREATMENT OF SUBFOVEAL CNV SECONDARY TO AMD

The purpose of this study was to evaluate the short-term safety and feasibility of intraocular, epiretinal delivery of beta radiation for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration for 12 months. A 3-year follow-up period is planned to assess the long-term safety of the procedure. In this nonrandomized, multicenter feasibility study, 34 treatment-naïve patients with predominantly classic, minimally classic, or occult lesions due to subfoveal choroidal neovascularization secondary to age-related macular degeneration received a single treatment with either 15 Gray (Gy) (8 patients) or 24 Gy (26 patients) beta radiation (strontium-90) using a novel intraocular delivery device. Adverse events and safety endpoints were observed and recorded. Visual acuity was measured preoperatively and postoperatively using standard Early Treatment Diabetic Retinopathy Study vision charts. Twelve months after treatment, no adverse events associated with exposure to radiation were observed. All patients in both 15 Gy (n = 4) and 24 Gy cohorts (n = 17) who met inclusion criteria and were treated according to protocol lost fewer than three lines of vision. Fifty percent (2/4) of the 15 Gy-treated patients and 76% (13/17) of the 24 Gy-treated patients improved or maintained their visual acuity at 12 months. In the 24 Gy group, 29% (5/17) gained three lines or more in visual acuity. The mean change in visual acuity observed at month 12 was +10.3 letters in the 24 Gy study cohort and -1.0 letters in the 15 Gy cohort. The short-term safety and efficacy of intraocular, epiretinal delivery of beta radiation for the treatment of subfoveal choroidal neovascularization was promising in this small study group and should be studied in a larger cohort of patients.

Running a small study group

Medical EducationVolume 6, Issue 3 p. 259-259 Running a small study group W. O. G. TAYLOR, W. O. G. TAYLOR Ophthalmologist in Administrative Charge, North and South Ayrshire Hospital Boards.Search for more papers by this author W. O. G. TAYLOR, W. O. G. TAYLOR Ophthalmologist in Administrative Charge, North and South Ayrshire Hospital Boards.Search for more papers by this author First published: September 1972 https://doi.org/10.1111/j.1365-2923.1972.tb01669.xRead the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume6, Issue3September 1972Pages 259-259 RelatedInformation

Chemoprevention of Colorectal Neoplasia by Estrogen: Potential Role of Vitamin D Activity

Postmenopausal hormone replacement therapy lowers colon cancer incidence. In humans, the mechanism is unknown, but animal models suggest that it may involve activation of the vitamin D receptor (VDR) pathway. The aims of our study were to determine whether estrogen intervention affects global gene expression in rectal mucosal biopsies and whether vitamin D-related genes are affected. Estradiol was given to raise serum estradiol to premenopausal levels in 10 postmenopausal women under close nutritional control. Primary end points were expression of VDR, CYP24A1, CYP27B1, and E-cadherin in rectal mucosa by reverse transcription-PCR and examining response to estradiol by genome-wide arrays. Responses in gene expression in rectal biopsies to estrogen were determined in each subject individually and compared with a human estrogen response gene array database and a custom array in vitro-generated database. Cluster analysis showed that subjects maintained their overall gene expression profile and that interindividual differences were greater than intraindividual differences after intervention. Eight of 10 subjects showed significant enrichment in estrogen-responsive genes. Gene array group analysis showed activation of the VDR pathway and down-regulation of inflammatory and immune signaling pathways. Reverse transcription-PCR analysis showed significant up-regulation of VDR and E-cadherin, a downstream target of vitamin D action. These data suggest that the chemopreventive action of hormone replacement therapy on colon neoplasia results, at least in part, from changes in vitamin D activity. Evaluation of gene arrays is useful in chemopreventive intervention studies in small groups of subjects.

Beyond groups: seven pillars of peopled ethnography in organizations and communities

We extend Fine's (2003) model of `peopled ethnography' for studying small groups to the study of larger social units, including organizations and communities. While studies of small groups often recognize the presence of macro-level social structures, they typically treat these as backdrops to the interaction scene which constrain and enable group life, not as units of analysis in their own right. Yet small groups are embedded in and help constitute larger units of analysis, such as organizations and communities. We argue that studies of these larger social structures can be extended beyond ethnographic observation of the interactions that help comprise them, making peopled ethnography applicable to units of analysis larger than the small group. We offer illustrative examples of organizational and community ethnographies.

Behavioral interventions to reduce risk for sexual transmission of HIV among men who have sex with men

Behavioral interventions to reduce risk for sexual transmission of HIV among men who have sex with men

3 Level Ventilation: the First Clinical Experience

Considering the issues of artificial ventilation (AV) in non-homogenous pathological lung processes (acute lung injury (ALI), acute respiratory distress syndrome (ARDS), pneumonia, etc.), the authors applied the three-level lung ventilation to a group of 12 patients with non-homogenous lung injury. Three-level ventilation was defined as a type (modification) of AV whose basic ventilation level was produced by the modes CMV, PCV or PS (ASB) and add-on level, the so-called background ventilation was generated by two levels of PEEP. PEEP (constant) and PEEPh (PEEP high) with varying frequency and duration of transition between the individual levels of PEEP. Objective: to elucidate whether in cases of considerably non-homogenous gas distribution in acute pathological disorders, three-level ventilation (3LV) can correct gas distribution into the so-called slow bronchoalveolar compartments, by decreasing the volume load of the so-called fast compartments and to improve lung gas exchange, by following the principles of safe ventilation. Results. 3LV was applied to 12 patients with severe non-homogenous lung injury/disorder (atypic pneumonia and ARDS/ALI) and low-success PCV ventilation after recruitment manoeuvre (PaO2 (kPA) /FiO2 = 5—6). There were pronounced positive changes in pulmonary gas exchange within 1—4 hours after initiation of 3LV at a fPCV of 26±4 breaths/min-1 and PEEPh at a fPEEPH of 7±2 breaths/min-1 with a minute ventilation of 12±4 l/min. 3LV reduced a intrapulmonary shunt fraction 50±5 to 30±5%, increased CO2 elimination, with PaCO2 falling to the values below 6±0.3 kPa, and PaO2 to 7.5±1.2 kPa, with FiO2 being decreased to 0.8—0.4. Lung recruitment also improved gas exchange: with PEEP=1.2±0.4 kPa, static tho-racopulmonary compliance (Cst) elevated from 0.18±0.02 l/kPa to 0.3±0.02 l/kPa and then to 0.38±0.05 l/kPa. Airways resistance (Raw) decreased by more than 30%. Improved lung aeration was also estimated as a manifestation of gas distribution with a long time constant. After 5±1-day 3LV, the patients were switched to PS ventilation; after gradually reduction of ventilation maintenance, they were disconnected from a ventilator and transferred to a specialized unit. Conclusion. The small study group made it impossible to statistically assess outcomes; the clinical results are not at least contrary to the results of theoretical mathematic simulation of 3LV in mathematical and physical models. 3LV as compared with PCV applied within the first 2—4 hours of AV improved lung gas exchange. It can be a promising mode of ventilation for the lungs afflicted by a diffusive non-homogenous pathological process. Key words: artificial ventilation, three-level ventilation, acute lung injury, acute respiratory distress syndrome.

Improving Decision Making in the Treatment of ADHD

Improving Decision Making in the Treatment of ADHD

Influence of Hand Cycling on Physical Capacity in the Rehabilitation of Persons With a Spinal Cord Injury: A Longitudinal Cohort Study

To investigate the influence of hand cycling on outcome measures of physical capacity during and after rehabilitation in persons with paraplegia and tetraplegia in The Netherlands. A longitudinal cohort study with measurement moments at the start (t1) and end (t2) of clinical rehabilitation and 1 year after discharge (t3). Hand cycle use was assessed by means of questionnaires at t2 and t3. Eight rehabilitation centers in The Netherlands. Subjects (N=162) with a recent spinal cord injury. All subjects followed the regular rehabilitation program. Peak oxygen uptake (Vo(2)peak) and peak power output (POpeak) determined in a handrim wheelchair peak exercise test, peak muscle strength of the upper extremities, and pulmonary function. A significantly larger increment in Vo(2)peak, POpeak, and elbow extension strength was found in subjects with paraplegia during clinical rehabilitation. No such effect was found in subjects with tetraplegia. In the postrehabilitation period, no influence of hand cycling on any outcome measure was found in subjects with paraplegia or subjects with tetraplegia. After correction for baseline values and confounders, regular hand cycling (once a week or more) appeared to be beneficial for improving aerobic physical capacity in persons with paraplegia during clinical rehabilitation. The small and heterogeneous study groups may have hampered the finding of positive results of hand cycling in persons with tetraplegia.

Circles Drawing Toward High Risk Activism: The Use of Usroh and Halaqa in Islamist Radical Movements

Kurzman (2004) argued that social movements research and Islamic studies “followed parallel trajectories, with few glances across the chasm that have separated them.” This article will illuminate one influential process that has relevance to both these areas, the use of small groups for the purpose or radical mobilization. Specifically, it examines the impact of the use of small Islamic study groups (usroh and halaqa) for fundamental and radical Islamic movements. Although small-group mobilization is not unique to Islam, the strategic use of these study groups empowered by the Islamic belief system has yielded significant returns in capacity building for high-risk activism.

Neuroimaging findings in children with rare or novel de novo chromosomal anomalies

De novo constitutional chromosomal anomalies provide important insights into the genetic loci responsible for congenital neurological disorders. However, most phenotypic descriptions of patients with rare chromosomal abnormalities are published as individual case reports or small group studies, making genotype-phenotype correlations unclear. Moreover, many clinical genetic reports do not include neuroimaging. We conducted a retrospective case series study of all children who had genetic testing done at Children's Memorial Hospital in Chicago, Illinois between 1985 and 2006. The case series was selected from a database containing all chromosomal testing results, clinical data, and neuroimaging. Clinical examination results were assigned by board certified geneticists and/or neurologists and neuroimages were reviewed by both a neurologist or neuroradiologist and a blinded neurologist. Of the 28,108 children in the series, we identified 34 children with novel or apparently novel de novo chromosomal abnormalities. Several of the cases represent potentially new genetic loci for neurological malformations and novel syndromic conditions. This study demonstrates the utility of large clinical databases in assessing genotype-phenotype correlations and mapping loci for congenital neurological disorders. We describe a case-series strategy to analyze existing databases to reveal new genotype-phenotype correlations.

Does a “one-stop” gynecology screening clinic for women in hereditary nonpolyposis colorectal cancer families have an impact on their psychological morbidity and perception of health?

Screening programs can reduce the burden of disease, however, they can be associated with raised levels of anxiety. The risk of endometrial and ovarian cancer is increased in hereditary nonpolyposis colorectal cancer (HNPCC). There is no prospective evidence to support screening for gynecological disease in HNPCC, however, current recommendations include the use of ultrasound and endometrial biopsy. This study assesses the impact of screening for gynecological cancer on self-reported symptoms of anxiety, depression, and perceptions of health. Women from HNPCC families attending gynecological screening (n = 26) completed the Hospital Anxiety and Depression Scale and the ShortForm36v2 questionnaires prior to screening with transvaginal ultrasound, outpatient/office hysteroscopy, endometrial biopsy, and ovarian tumor marker assessment (CA125). The same questionnaires were completed at 3 and 6 months following screening (15/26). Women in HNPCC families attending for gynecological screening did not have excess symptoms of anxiety or depression at baseline in subjective comparison to other populations. The process of screening and false positive screening results had no significant impact on symptoms of anxiety and depression or perceptions of health. We conclude that within the limitations of analysis in this small study group, screening for gynecological disease in HNPCC does not appear to be associated with any psychological morbidity.

A comparative evaluation of the Adaptive® knee and Catech® knee joints

The Adaptive knee joint is a microprocessor-controlled prosthetic knee that incorporates both pneumatic and hydraulic control in one electronic unit. Pneumatic control is said to provide control during swing phase and the hydraulic control during the stance phase of the gait. This hybrid controller is triggered by a computer contained within the knee that responds to input from force, time and angle sensors. The microprocessor then selects an appropriate speed and stability setting. The Catech knee joint is a conventional hydraulic knee joint. The aim of this study was to compare the Adaptive and Catech knee joints in established trans-femoral amputees. The patients meeting the inclusion criteria were all established trans-femoral amputees using the Catech knee joint. The study was carried out by performing gait analysis, assessing energy requirements using the Physiological Cost Index (PCI) and using questionnaires. There was no significant benefit gained from the use of the Adaptive knee over the Catech knee joint in our small study group.

Early detection of leptomeningeal metastasis in patients with metastatic breast carcinoma: validation of CA 15-3 measurement in cerebrospinal fluid

Fifteen per cent of metastatic breast cancer will develop symptomatic leptomeningeal metastases. The introduction of trastuzumab (Herceptin) therapy has improved the response rates of survival of patients with metastatic breast cancer overexpressing HER2. Although previous studies are retrospective and of limited number, involving small study groups and different types of patient management, several authors have reported a 30% incidence of leptomeningeal metastases in patients with metastatic breast cancer overexpressing HER2 who were treated with trastuzumab, while 70 to 80% of cases of the disease were controlled systemically. In order to improve control of the disease at the level of the central nervous system (CNS), routine detection of leptomeningeal metastases in high-risk patients could be offered. CA 15-3 in cerebrospinal fluid (CSF) detection might be useful in helping to diagnose CNS metastases, particularly where cytology results are negative--which applies to 30% of cases--because tumor markers are more sensitive in detecting the tumor process. Our study validate CA 15-3 measurement in CSF and reference values were given.

지구과학 교사 연구 모임 참여 교사의 야외 지질 학습 지도에 대한 인식과 실행에 대한 사례 연구

본 연구의 목적은 지구과학 교사 연구 모임에 참여하고 있는 교사의 야외 지질 학습에 관한 인식과 실행을 조사하는 것이다. 연구 참여자는 은대리 지역의 야외 지질 학습에 지도 교사로 참여한 지구과학 교사 4명이다. 자료 수집은 야외 지질 학습 수업 관찰 및 녹화, 학생들과 교사들을 대상으로 한 반구조화된 심층면담, 야외 지질 학습 수업 자료 및 학생 보고서 등을 통해 이루어졌으며, 야외 지질 학습 수업 및 면담 자료를 전사한 후 질적 분석을 하였다. 연구 결과에 의하면 연구 참여 교사들은 대체로 야외 지질 학습의 목적으로 심미적인 측면을 중요시하고 있었고, 실제 연구 참여 교사들의 야외 수업에서 학생들이 과학적 탐구에 참여할 수 있는 다양한 교수 방법과 전략이 활용되고 있었지만, 각 관찰 지점에서의 제한된 시간 등으로 인하여 학생들의 활동보다는 교사의 설명이 더 많은 야외 강의의 측면이 보였다. 연구 참여 교사들은 교사 연구 모임과 야외 지질 답사 참가, 대학원 진학 등을 통해 야외 지질 학습 지도를 위한 전문성 개발에 계속적인 노력을 해오고 있었다. The purpose of this study was to investigate the perceptions and practices of secondary science teachers who participated in an Earth science teachers' research roup about teaching geologic field trips. Four Earth science teachers participated in this study. Data included field trip observations, semi-structured interviews with teachers and students, and analysis of instructional materials and students' reports from the field trip. Field trip observations and interviews were video- and audio-taped and transcribed. Results indicated that teacher participants focused more on aesthetic objectives for geologic field trip. The participants' instruction tended to show rather teacher-centered explanation due to limited time at each field site though various teaching strategies were used at times to engage students in a scientific inquiry. This group of teachers strived to develop their professional ability to guide geologic field trip by working with a small study group with colleagues, participating geologic field trips, and enrolling graduate programs.

Chest physiotherapy and outcomes in ICU

Sir: Thank you for the opportunity to reply to correspondents Beraldo and Timenetsky, who raise concerns regarding our use of statistics and suggest that we should have used ventilator-free days, as suggested by Schoenfeld and Bernard, as an alternative to the standard Kaplan–Meier analyses [1]. We considered the use of ventilator-free days as a new approach to analysing data. We had a number of reservations. Firstly, it is a new technique which has not been evaluated other than by those who suggested it. Secondly, the concept of ventilator-free days is not as tangible as the median time to become ventilator-free, which is generally clearer; however our main concern, which we raised at the initial presentation of the data at the European Society of Intensive Care meeting in Barcelona, was that it was an arbitrary calculation. Like Kaplan–Meier it effectively censures death, but the choice of 28 days is arbitrary. For example, at the meeting we demonstrated that the null hypothesis was rejected variably depending on the arbitrary cut-off point, the significance reducing progressively if the cut-off point increased from 10 to 35 days. The majority of our patients were discharged from intensive care by the second week; thus, a cut-off point of 28 days made no sense since the end point of the study had long passed. Mortality was separately analysed. Consequently, we opted to use conventional methodology. A second concern was the possible influence of the non-significantly higher APACHE II ICU day-1 risk of death among the physiotherapy group, which might have biased the results adversely. We propose that the groups had similar risks of death and actual mortality rates, suggesting equipoise rather than bias. It is well known that acuity-score-based probability of death estimates have considerable intrinsic error particularly with small populations of heterogeneous patients, such as in our study. Perhaps the correspondents are suggesting that such was the impact of physiotherapy that it improved outcome among the “sicker” physiotherapy group and matched the non-physiotherapy patients. This would have been an over-interpretation, and unlikely given that few critical care interventions on small study groups of heterogeneous patients, such as ours, have been demonstrated to improve outcome. Furthermore, the correspondents should bear in mind that the median statistic based on the Kaplan–Meier curve looks at the first 50% of patients in each group, whereas the statistic for APACHE II risk of death was based on all the patients in each group. Secondly, APACHE II reflects acuity on day 1. These patients were recruited after 48 h, and for this reason SOFA scores were included to indicate acuity at the time of recruitment; again, these were non-significantly different. The correspondents suggest that the greater number of neurosurgical patients in the physiotherapy group might have introduced bias against the physiotherapy group. We disagree. Neurosurgical patients invariably had a tracheotomy and had the advantage of meeting an easier ventilator-free end point, namely spontaneous ventilation on a CPAP circuit through a tracheotomy determined a priori. By contrast, the control group had fewer tracheotomies and had to achieve the more difficult ventilator-free end point of breathing spontaneously on a face mask.

Phase I, double-blind, randomized, placebo-controlled, dose-escalation study of the effects on blood pressure of abrupt cessation versus taper down of guanfacine extended-release tablets in adults aged 19 to 24 years

Background: Guanfacine hydrochloride is an α 2a-adrenoreceptor agonist found to be effective in the treatment of attention-deficit/hyperactivity disorder (ADHD). Because the available immediate-release formulation requires multiple daily dosing and has been associated with rebound hypertension on abrupt cessation, an extended-release (ER) formulation has been developed for study of efficacy and tolerability parameters in patients with ADHD. Objective: This trial was primarily undertaken to determine the effect on blood pressure (BP) of abrupt cessation versus taper-down of guanfacine ER. Methods: This Phase I, randomized, double-blind, placebo-controlled, dose-escalation trial was conducted at MDS Pharma Services, Lincoln, Nebraska. Male and female healthy young-adult (aged 19-24 years) volunteers were included. Subjects were randomly assigned to receive guanfacine ER as follows. Abrupt-cessation and taper-down groups both received guanfacine ER at forced titration: 1 mg on days 1 to 4, 2 mg on days 5 to 8, 3 mg on days 9 to 12, and 4 mg on days 13 to 16. The abrupt-cessation group then received placebo daily on days 17 to 32. The taper-down group began the following taper-down schedule: 3 mg on days 17 to 20, 2 mg on days 21 to 24, 1 mg on days 25 to 30, and placebo on days 31 to 32. Placebo was administered daily to the subjects in the placebo group (days 1–32). All doses were given in the morning. Tolerability was assessed before (at the 8-hour baseline visit), during (approximately every 4 days and during 48-hour confinements at days 17/18 and 31/32), and 7 days after the study and included assessment of BP and pulse, 12-lead electrocardiography (ECG), and laboratory assays. Adverse events (AEs) were also tracked every 4 days beginning on day 5 and 7, 14, and 30 days poststudy by recording responses and follow-up to a nonleading question about how the patient was feeling that day. Results: Forty-five subjects were enrolled in the study (15 in each group), and 35 subjects completed it. The mean age of study participants was 22 years, 87% were white, and the ratio of women to men was 2:1. There were no marked differences between groups regarding age, sex, or race. Compared with the taperdown group, the abrupt-cessation group did not exhibit a clinically significant elevation of systolic BP (SBP) or diastolic BP (DBP) or other tolerability parameters, including AEs. Significant differences in BP were observed on days 17/18 (first day of abrupt cessation) and 31/32, but the overall means were not statistically different. The SBP decreases were −7.55% (−8.84 mm Hg) in the abrupt-cessation group and −8.33% (−9.69 mm Hg) in the taper-down group. The DBP decreases were −9.14% (−6.17 mm Hg) in the abrupt-cessation group and −9.94% (−6.59 mm Hg) in the taper-down group. There were no statistically significant or clinically important differences in change or percentage change in pulse from baseline to day 31/32 between the taper-down and placebo groups (least squares mean difference, 2.26 bpm). None of the subjects experienced bradycardia. No clinically important treatment related trends were noted in the clinical laboratory, ECG, or physical examination findings, including vital signs. No serious treatment-emergent AEs were reported in this study. Overall, 124 treatment-emergent AEs were reported in 29 (64%) subjects. Treatment-emergent AEs were reported in 14 (93.3%) of 15 subjects in the abrupt-cessation group, 8 (53.3%) of 15 subjects in the taper-down group, and 7 (46.7%) of 15 subjects in the placebo group. Headache was the most common AE reported in the abrupt-cessation (46.7%) and placebo (13.3%) groups. For the taper down group, it was dry mouth (26.7%). All AEs were classified as mild or moderate. Conclusion: In this small study group of healthy, young-adult volunteers, guanfacine ER at doses up to 4 mg/d was abruptly discontinued without significant increases in SBP or DBP or other tolerability parameters, including AEs, compared with taper.

Clinical, behavioural and polysomnographic correlates of cataplexy in patients with narcolepsy/cataplexy

Background Cataplexy is the main motor symptom of narcolepsy/cataplexy and is considered a form of rapid eye movement (REM) sleep motor dyscontrol appearing during wakefulness and elicited by emotions. This study examined the relationship between the frequency of cataplectic attacks in patients with narcolepsy/cataplexy and (a) the clinical and behavioural characteristics of cataplectic attacks, including the emotional tone of trigger events, and (b) the polysomnographic characteristics of daytime sleepiness, nocturnal sleep structure and indices of motor disorders during sleep. Methods A consecutive series of 44 first-diagnosed drug-naive patients with narcolepsy/cataplexy, fulfilling the International Classification of Sleep Disorders, 2nd edition (ICSD-2) clinical and polysomnographic diagnostic criteria, were interviewed to estimate the frequency and clinical characteristics of cataplectic attacks and the occurrence of REM sleep behaviour disorder (RBD). All patients also underwent a video-polysomnographic recording to assess their sleep parameters and indices of altered motor control during sleep. Results Patients were divided into two groups on the basis of the frequency of cataplectic attacks, namely high-frequency ( n = 30) or low-frequency ( n = 14) depending on whether they estimated they had more or less than one attack per month. High-frequency patients (with a larger proportion of men) reported attacks more often affecting mainly the head, jaw and shoulder muscles and experienced more events among those listed as possible triggers of attacks. Sixty-one percent of patients reported RBD and 43% had an RBD episode at video-polysomnography regardless of the frequency of cataplectic attacks or gender. Lastly, the frequency of periodic leg movements (PLM) per hour was higher in men than women and increased with age. Conclusions Patients with more than one cataplectic attack per month had more frequent involvement of head, jaw and shoulder muscles and were mainly men. The proportions of patients with clinically assessed RBD and an RBD episode documented by video-polysomnography, as well as conspicuous values of PLM per hour, are fairly consistent with those reported in recent small-group studies. Therefore, it seems legitimate to argue that RBD and PLM are nocturnal manifestations intrinsic to narcolepsy/cataplexy and that the gender-related differences in the frequency of attacks and the value of PLM per hour may be indicative of a larger difference in the clinical and polysomnographic characteristics of narcolepsy/cataplexy than hitherto suspected.